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Design Rationale & Surgical Technique
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Delta XTEND Design Rationale

Jan 15, 2017

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Page 1: Delta XTEND Design Rationale

Design Rationale & Surgical Technique

Page 2: Delta XTEND Design Rationale

32

Described by Charles Neer in 19831, the shoulder pathology known as Cuff Tear Arthropathy (CTA) has historically been seen as a significant surgical challenge.

Non-constrained total or hemi shoulder arthroplasties have limited clinical outcomes in such indications, and most of the constrained and semi-constrained prostheses developed in the 1970’s-1980’s for CTA (in particular, all reversed ball and socket designs) remained purely experimental due to poor motion capability, instability and a high rate of glenoid loosening.2,6,15

In 1985, Paul Grammont (Dijon University Hospital – France) designed the first semi-constrained reverse concept that met the challenges inherent in cuff tear arthropathy cases3. Known today as the DePuy Delta CTA®, this shoulder prosthesis is a leading treatment for shoulder cuff tear arthropathy4, with more than twenty years of clinical success and 20,000 cases performed all over the world.

Based on the experience of the Delta CTA® System, the next generation of reverse shoulder arthroplasty, the DePuy Delta XTEND™ prosthesis has been designed using scientific, engineering, and clinical knowledge in CTA cases in order to extend the clinical success associated with the 20 year history of the Delta CTA system.

Keeping the three design features that differentiated the Delta CTA system from previous reverse designs and made it successful:

• Jointcenterofrotationpositionedontheglenoidbonesurfacetoavoid pull-out torques on the glenoid component5

• Non-anatomicneck-shaftangle(155degrees)forjointstability3,6

• Optimaldeltoidtensioningtomaximizeitsactionwithoutover-stretchingthetissues5

Reducingtheriskofscapularneckerosionandmaximizingtheshoulderrangeofmotion:7,8 • Inferioroverlapoftheglenoidcomponentallowedbyaneweccentricglenospheredesign and a new metaglene fixation system

Preserving bone to permit intervention and faster recovery with: • Curved-backmetaglenedesign9 • Reducedproximalgeometrymonoblochumeralstemforcementedapplication • Cementlessmodularstemwitheccentricepiphysisoption

Design based on the success of the Delta CTA Reverse Shoulder means that the Delta XTEND System is the next step forward for management of patients with Cuff Tear Arthropathy. The Delta XTEND System allows you to treat more patients, effectively.

Dr. Didier Capon France

Dr. David Collins USA

Prof. Anders Ekelund Sweden

Dr. Laurent Lafosse France

Prof. Lieven De Wilde Belgium

Dr. Cécile Nérot France

Dr. Ludwig Seebauer Germany

Dr. Michael Wirth USA

The Delta XTEND™ Surgeon Design Team

Page 3: Delta XTEND Design Rationale

32

Contents

Design Rationale

Cementless Modular Stem ......................................4

Cemented Monobloc Humeral Implant .................4

Modular Epiphysis ...................................................4

Polyethylene Humeral Cups ...................................5

Humeral Cup Depth ................................................5

Glenoid Component ...............................................5

Delta XTEND® CTA Heads .......................................5

Premieron™ X-Linked Polyethylene ...................6-7

Surgical Technique

Delta XTEND Key Surgical Steps ........................ 8-9

Pre-operative Templating and Patient Positioning ........................................ 11

Surgical Approach ................................................. 11

Intramedullary Canal Preparation .......................14

Humeral Head Resection .................................15-17

Exposing the Glenoid.......................................18-19

Positioning the Metaglene Central Peg ........ 20-22

Reaming the Glenoid Bone ............................ 23-24

Metaglene Implantation ......................................25

Inferior and Superior Metaglene Screw Placement .......................... 26-29

Anterior and Posterior Metaglene Screw Placement .......................... 30-31

Placement of the Proximal Humeral Reaming Guide ......................................32

Proximal Humeral Reaming Cementless Modular Humeral Implants ........ 33-34

Distal Humeral Broaching Cementless Modular Humeral Implants ..............35

Humeral Trial Stem and Epiphysis Insertion Cementless Modular Humeral Implants ........ 36-37

Proximal Humeral Reaming Cemented Monobloc Humeral Implants .............38

Humeral Trial Implant Insertion Cemented Monobloc Humeral Implants .............39

Glenosphere Trial Placement ................................40

Cup Trials and Trial Reduction ..............................41

Joint Tensioning and Stability Assessment ..........42

Definitive Glenosphere Fixation .................... 43-45

Definitive Humeral Implant Insertion Cementless Modular Humeral Implants ..............46

Definitive Humeral Implants Insertion Cemented Monobloc Humeral Implants .............47

Definitive Humeral Implant Insertion ............ 48-50

Cases of Proximal Humeral Bone Loss ............51-52

Revision to Hemi-Arthroplasty .............................53

Post-Operative Management ...............................54

Ordering Information

Implants ........................................................... 55-57

Instrumentation .............................................. 58-61

Page 4: Delta XTEND Design Rationale

54

1 2

5

3

6

4

Delta XTEND Design RationaleThe Delta XTEND System is a total, semi-constrained shoulder arthroplasty that reverses the normal relationship between

the scapular and humeral components, moving the scapulo-humeral joint center of rotation medially and inferiorly,

increasing the deltoid lever arm as well as the deltoid tension and therefore allowing the muscles of the deltoid group to

compensate for rotator cuff deficiency.5 The Delta XTEND humeral stem is designed for cemented fixation. The glenoid

component is cementless with four screws as primary fixation and HA coating for secondary fixation. Each design feature

has been defined to help achieve the clinical goals for CTA cases with the Delta XTEND Reverse Shoulder.

1

2

3

4Cemented Monobloc Humeral Implant

Polishedcobaltchromiumalloyforoptimizedcementedfixation12

155° neck shaft angle for optimal joint stability6

Reduced proximal geometry for bone preservation

Standard and long monobloc stems with smooth,

perforated fins and proximal height laser

markings for use in proximal bone

loss cases

1

2

4

3

1

2

Cementless Modular Stem

Fluted stem design based on the Global®

shoulder stem design - positioned in anatomic

version for optimal press-fit fixation9

Hydroxyapatite (HA) coated titanium alloy

for optimal cementless application10

5

4

3

6

Modular Epiphysis

Positioned at 0-10° retroversion for increased internal rotation11

Centered and eccentric options to suit to

anatomyandoptimizepress-fitfixation

155° neck shaft angle for optimal joint stability6

Reduced dimensions for bone preservation

Page 5: Delta XTEND Design Rationale

54

6

7

8

9

5

6

7

9

8

5

2mm2mm

Humeral Cup Depth

High Mobility Standard Retentive

Glenoid Component

Increased glenosphere diameter (38 and 42mm)

and eccentric option for improved stability,

maximizedrangeofmotionandreducedriskof

scapular erosion8

Center of rotation on glenoid bone surface for

high resistance to loosening shear forces5,8,13

Two locking variable angle screws (compress and

lock) and two compression screws with +/- 10

degrees adjustable angulation for metaglene

primaryfixation,tomaximizeresistanceto

loosening shear forces13

Curved back and smaller metaglene, for bone

preservation and low positioning on the glenoid

to reduce risk of scapular bone erosion8,13

Polyethylene Humeral Cups

+3,+6and+9mmcupsizesareavailableto

adjust joint tension for optimal deltoid function

based on clinical heritage4,5

Delta XTEND CTA Heads

• Hemi-headsavailableintwo

diameters and two head heights for

easy revision from reverse to hemi-

arthroplasty

• Extendedarticularsurfacefor

improved potential range of motion

INCREASING CONSTRAINT

Page 6: Delta XTEND Design Rationale

76

Premieron™ X-Linked Polyethylene

X-traordinary Mechanical Integrity

Optimal Balance

Today’s shoulder patients demand more from their

replacements than ever before. Their active lifestyles

can benefit from the significant advances in wear

reduction offered by moderately crosslinked polyethylene.

Premieron balances wear reduction and mechanical

integrity while maintaining oxidative stability through an

exclusive scientific formulation that has been proven to

provide improved resistance to the multidirectional wear

typical of shoulder implants.16

Materals and Process:

• GUR1020polyethyleneresin

• 5Mradofirradiationinducesmoderatecross-linking

• Thermallytreatedto155degreestoeliminatefree

radicals for an oxidatively stable material

• Gasplasmaterminalsterilization

X-traordinary Wear Reduction

Proven Performance

DePuyOrthopaedicsofferspolyethylenesolutions

optimizedfortheuniquedemandsofeachshoulder

joint. Premieron™ X-Linked Polyethylene creates

a technologically advanced shoulder implant that

has demonstrated an 85% reduction in wear debris

overconventionallymanufacturedandsterilized

components.16 In shoulder simulator testing, Premieron

significantly lowered the calculated osteolytic potential,

and thus the risk of aseptic loosening.

X-acting Biomechanical Criteria

Range of Motion

The significant wear resistance of Premieron, coupled

with the design of Delta XTEND humeral cup implants,

addresses the unique biomechanical concerns associated

with semi-constrained reverse shoulder prostheses. This

combination, based on a long clinical heritage, enables

optimal deltoid use and balanced soft tissue tension while

reducing the risk of joint overtensioning, nerve injury, or

acromial failure.

Gra

vim

etric

Wea

r (m

g/M

c)

Conventional

10

20

30

40

50

Crosslinked

85% Reduction

WearResistance

ManufacturingProcess

MechanicalIntegrity

OxidativeStability

Page 7: Delta XTEND Design Rationale

76

Premieron X-linked polyethylene improves resistance to the multi-directional wear generated by shoulder

implants and increases durability without compromising mechanical properties.16,17

Optimal Mechanical Integrity And Wear Reduction

Too Little = Limited Wear Reduction

Too Much = Limited Mechanical Integrity

CROSSLINKED RADIATION DOSAGE (Mrad)

Page 8: Delta XTEND Design Rationale

98

Delta XTEND™ Key Surgical StepsHumeral Surgical Steps

2. Humeral Head Resection

1. Approach

2. Humeral Head Resection

1. Approach

Superior-lateral Approach

Delto-pectoral Approach

3. Metaglene Central Peg Drilling

2. Cannulated Glenoid Reaming1. Choice of Optimal Metaglene Positioning

Glenoid Surgical Steps

Modular Implant Cementless Technique

Monobloc Implant Cemented Technique

3. Proximal Reaming Guide Positioning

Page 9: Delta XTEND Design Rationale

98

4. Metaglene Impaction 5. Inferior and Superior Locking Screw Fixation

6. Anterior and Posterior Spherical Head Screw Fixation

7. Glenosphere Implantation

Glenoid Surgical Steps

Modular Implant Cementless Technique

Monobloc Implant Cemented Technique

4. Determination of the Epiphysis Size

5. Proximal Humeral Reaming

6. Final Implant Insertion

7. Cup Impaction

4. Determination of the Epiphysis Size and Eccentricity

5. Proximal Humeral Reaming

6. Diaphyseal Broaching and Angulation Measurements

7. Epiphysis / Diaphysis Assembly

8. Final Implant Insertion

9. Cup Impaction

StandardOption EccentricOption

Humeral Surgical Steps

Page 10: Delta XTEND Design Rationale

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Pre-operative Templating

An initial assessment of the glenoid bone should be

carried out using radiographic and CT imaging to

determine whether the patient is suitable for treatment.

Thesizeoftheglenoidvaultshouldbeassessedinferiorly

in particular to ensure that all four metaglene screws can

be placed within glenoid bone.

Pre-operative planning

should also be carried

out using AP and lateral

shoulder radiographs of

known magnification

and the available

template to help the

surgeon determine the

sizeandalignmentof

the implant (Figure 1).

The final decision

should be made

intraoperatively.

Patient Positioning

The patient should be in the beach chair position, with

the affected arm completely free and on a support

(Figure 2).

Pre-Operative Templating and Patient Positioning

Figure 1

Figure 2

Surgical Approach

The Delta XTEND prosthesis can be implanted using

a superior-lateral deltoid split approach or a delto-

pectoral approach.

Thesuperior-lateralapproachenablesclearvisualization

of the glenoid and therefore facilitates the implantation

of the glenoid components.

The delto-pectoral approach has the advantage of

offering a good view of the inferior part of the glenoid.

Therefore, the choice mainly depends on the surgeon’s

preference and clinical parameters.

Revision surgery, for instance, is usually performed using

a delto-pectoral approach since the patient has already

had that incision and since it allows for a longer humeral

incision when faced with difficult removal of the humeral

stem. However, for cases of retroverted glenoid, the

implant placement can be more difficult via the delto-

pectoral approach and can lead to damage of the deltoid

muscle. Moreover, as the rotator cuff lesion is mainly

located at the supero-posterior aspect of the cuff, the

(partial) insertion of the remaining subscapularis (that

is often needed through this approach) could weaken

the remaining muscular structure. The superior-lateral

approach may be preferred in these cases.

Page 12: Delta XTEND Design Rationale

1312

Superior-lateral Approach

The skin incision is 10-12cm long and can be

antero-posterior along the lateral edge of

the acromion or made in a lateral direction

(Figure 3). Following subcutaneous dissection,

separate the anterior and middle deltoid

muscle bundles opposite the lateral margin of

the acromion using blunt dissection (Figure 4).

The dissection starts at the level of the AC

joint, 5-7mm posterior to the tip of the

acromion, and extends straight laterally down

into the deltoid muscle. It should not extend

more than 4cm from the external aspect of

the acromion in order to preserve the axillary

nerve which is located at the turning fold of

the subacromial bursa.

When the subacromial bursa is visible,

gentle longitudinal traction in line with the

limb allows a retractor to be placed in the

subacromial space. The anterior deltoid is

then released subperiosteally from its acromial

insertion up to the AC joint. The deltoid

release from the anterior acromion can include

a small piece of bone to facilitate repair and to

protect the deltoid muscle.

Oncethesubacromialbursahasbeen

removed, the humeral head is visible at the

anterior edge of the acromion. Exposure may

be improved, if necessary, by dividing the AC

ligament and performing acromioplasty.

The limb is then externally rotated and the

head is dislocated antero-superiorly to facilitate

positioning of the cutting guide. If the bicep

tendon is still present, a tenotomy or tenodesis

should be performed. The subscapularis,

teres minor and infraspinatus are retained

when present. A partial detachment of the

subscapularis may be performed when the

superior dislocation of the humerus is difficult

to obtain.

Figure 4

Figure 3

Surgical Technique

Page 13: Delta XTEND Design Rationale

1312

Delto-pectoral Approach

The skin incision follows the line from the

midpoint of the clavicle to the midpoint of

the arm (Figure 5). Subcutaneous flaps are

elevated to expose the fatty strip that marks

the delto-pectoral interval. Dissect medial

to the cephalic vein and retract it laterally

with the deltoid muscle (Figure 6). Incise the

clavipectoral fascia from the inferior border

of the coracoacromial ligament distally to the

superior border of the tendon of the sternal

head of the pectoralis major (Figure 7). Sharply

and bluntly dissect the humeroscapular

motion interface (subacromial, subdeltoid and

subcoracoid). Palpate the axillary nerve at the

anterior-inferior border of the subscapularis

muscle. Electrocoagulate or ligate the anterior

humeral circumflex vessels near the humerus

at the inferior border of the subscapularis

(Figure 8).

If the bicep’s long head tendon is intact, open

its sheath and tenodese the tendon in the

groove or to the pectoralis major tendon with

non-absorbable sutures. Excise the proximal

biceps tendon and hypertrophic sheath. A

biceps tenotomy can also be performed in

elderly patients.

Place a tag suture in the tendon of the

subscapularis, 2cm medial to its point of

insertion, in the lesser tuberosity. Release the

tendon, along with the underlying capsule,

from the lesser tuberosity and the proximal

humerus (Figure 9). Strip the remaining

inferior and posterior-inferior capsule from

the humerus. Dislocate the humeral head

(Figure 10).

Figure 9 Figure 10

Figure 7 Figure 8

Figure 5 Figure 6

Page 14: Delta XTEND Design Rationale

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Proximal Entry Point

Intramedullary Canal Preparation

Using the 6mm medullary canal reamer, make

a pilot hole in the cortical surface of the bone

eccentrically and as superior as possible so

that the reamer passes directly down the

intramedullary canal (Figure 11). Ream the

medullary canal using the T-Handle on the

reamer. Do not use a power tool as this could

remove more bone than necessary.

When using the standard length prosthesis,

pass the reamer down the intramedullary

canal until the projecting circular mark on

the reamer is level with the pilot hole. When

using the long stem prosthesis, pass the

entire length of the cutting flutes down the

intramedullary canal.

Continue to ream sequentially until the

reamer begins to bite on the cortical bone

of the intramedullary canal of the humerus

(Figure 12).

Thefinalreamersizewilldeterminethesize

of the cutting guide handle, the epiphyseal

reaming guide, the broach, trial stem and final

implant. For example, if the 12mm reamer

begins to gain purchase in the intramedullary

cortical bone, use a 12mm humeral trial stem

and final component.

Figure 11

Figure 12

Page 15: Delta XTEND Design Rationale

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Forearm Axis

0 to 10° Retroversion

Superior-lateral Cutting Guide Assembly

Delto-pectoral Cutting Guide Assembly

Figure 14

Humeral Head Resection

Figure 13

Select the handle for the cutting guide of the

appropriatesize.Takingthepreviousexample,

if reaming stopped at 12mm, select the 12mm

handle. Select the cutting guide and cutting

plate according to the surgical approach used

(superior-lateral or delto-pectoral).

Assemble the plate on the cutting guide

first (1) and then fix the cutting guide on the

cutting handle (2) (Figure 13).

The cutting guide should be fully seated on

the cutting handle.

Drive the cutting assembly down the

intramedullary canal until it is fully in contact

with the top of the humeral head. The

orientation pin is then passed through the

hole in the cutting handle in the desired

retroversion. The retroversion is calculated

with reference to the forearm axis. This

should preferably be close to 0 to 10 degrees

since excessive retroversion can restrict joint

rotation, especially internal rotation. The

cutting handle should then be turned to align

the orientation pin and the forearm (Figure 14).

(1)

(2)Cutting Guide

Cutting Guide Handle

Cutting Plate

(1)

(2)

Cutting Guide

Cutting Guide Handle

Cutting Plate

(1)

(2) Cutting Guide

Cutting Plate

Left Shoulder

Anteversion

Retroversion

Retroversion

Anteversion

Right Shoulder

30°20°10°0°10°20°30°

30°20°10°0°10°20°30°

Page 16: Delta XTEND Design Rationale

1716

Delto-pectoral ApproachSuperior-lateral Approach

Superior-lateral Cutting Plate Delto-pectoral Cutting Plate

Slide the cutting plate to adjust the resection

level. The cutting plate color code shows if the

resection level is appropriate. If the cutting

level indicator is green, the guide is at the

correct height. If it is red, the cutting plate

needs to be adjusted (Figure 15).

Visually verify that the resection is 1 to 2mm

below the proximal area of the greater

tuberosity (at the level of the supraspinatus

insertion in an intact shoulder).

Note that the angle of the cut is 155 degrees

and therefore different from the anatomical

neck/shaft angle (135 degrees). This angle

gives optimal joint stability to the reverse

prosthesis.6

Pre-drill the cortical bone through the cutting

plate using a 3.2mm drill bit, and insert the

two fixation pins to fix the cutting plate to the

humerus (Figure 16).

Figure 16

Figure 15

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1716

Delto-pectoral Approach Superior-lateral Approach

Remove the cutting guide and add a third

fixation pin through the cutting plate to secure

the assembly and resect the humeral head,

aligning the saw blade with the superior aspect

of the cutting plate (Figure 17, Step 1).

Note: The two external pins are parallel. The

cutting plate can therefore be turned upside

down before securing it with the third pin

to obtain a flat surface (Figure 17, Step 2).

Place a protecting plate on the humeral

resection surface to protect the bone from

damage during the following surgical steps

(Figure 18).

Pass a forked retractor under the scapula to

lower the humerus. If this provides a clear

view of the glenoid surface, the resection

level is correct. If not, a further humeral head

resection may be performed.

Figure 17

Figure 18

Step 2 Step 2

Step 1 Step 1

Page 18: Delta XTEND Design Rationale

1918

Figure 19

Exposing The Glenoid

Position a forked retractor in the axillary

margin of the scapula under the inferior

glenoid labrum to move the humerus down or

backward, depending on the approach taken

(Figure 19).

When exposing the glenoid, it is critical to note

the presence of the axillary nerve and protect

it at all times. Excise the biceps remnant and

entire labrum. Release the entire capsule

from around the glenoid. In certain cases, the

capsule may have to be excised depending

on the extent of any contractures and the

adequacy of exposure. In some cases, the

origin of the triceps long head may be incised

from the infraglenoid tubercle.

Bluntly (finger or elevator) dissect in a

circumferential manner from the base of the

coracoid process to well beyond the most

inferior aspect of the glenoid. It is essential

to palpate the following osseous scapular

orientation points: the base of the coracoid

process, the inferior part of the glenoid neck

and, when possible, infra glenoid tubercle and

lateral border of the scapula. Retractors should

be placed so that the entire glenoid face is in

clear view to aid accurate placement of the

guide pin.

Page 19: Delta XTEND Design Rationale

1918

Figure 20

Subscapularis Mobilization in

the Delto-pectoral Approach

Both sharp and blunt methods are used

tomobilizethesubscapularis.Completely

release the rotator interval to the base of the

coracoid process and release the superior

border of the subscapularis from the base of

the coracoid process. Then completely release

the motion interface between the coracoid

muscles (conjoined tendon) and the anterior

subscapularis. Lastly, completely release the

posterior border of the subscapularis tendon

and distal muscle belly from the anterior and

anterior-inferior glenoid rim, glenoid neck and

the most lateral part of the scapular body.

Glenoid Preparation

Remove any remnants of labrum from the

glenoid. Then remove all articular cartilage

(large straight curette) from the glenoid face.

In addition, any osteophytes present may

also have to be removed to determine the

bony anatomy (Figure 20).

Page 20: Delta XTEND Design Rationale

2120

Positioning of the metaglene is important to

achieve an optimal glenoid fixation, to limit

potential bone impingement and to achieve a

final good, stable range of motion. Therefore,

particular attention should be given to that

surgical step.

Thepositionchosenshouldmaximizecontact

with the glenoid bone surface and to allow

secure fixation of the screws in bone.

The metaglene should ideally be positioned

on the lower circular area of the glenoid bone.

The metaglene central peg is positioned in

the center of the inferior circle of the glenoid

(This point is often posterior and inferior to the

intersection of the glenoid axis) (Figure 21).

These anatomical reference points help to

position the metaglene as inferior as possible

on the glenoid bone in order to limit potential

bone impingement, while keeping a secure

glenoid implant fixation. However, radiographic,

CT images combined with X-ray templates

and pre-operative view can lead to a choice

of position a little bit more superior to obtain

fixation in good bone stock and complete

seating of the metaglene on the bone.

Positioning the Metaglene Central Peg

Figure 21

Page 21: Delta XTEND Design Rationale

2120

The metaglene positioner is used to obtain the

optimal metaglene position. The positioner

plate is the same diameter as the metaglene.

Assemble the positioner by inserting and

threading the internal rod into the positioner

handle (Figure 22).

Insert the hex head tip of the handle in

the corresponding plate hole (right or left

depending on the shoulder being operated

upon) and lock the assembly by tightening the

internal rod (Figure 23).

Note: The handle is set at an angle

of 20 degrees to the plate to ensure

optimal visibility (Figure 24).

Figure 22

Figure 24

Figure 23

20°

Page 22: Delta XTEND Design Rationale

2322

Position the plate as low as possible so that its

border follows the inferior edge of the glenoid.

Note that inferior osteophytes may result in

malpositioning. X-rays should therefore be

checked to avoid this problem.

Providing that the morphology of the glenoid

hasn’t been altered by the disease, the guide

plate is perpendicular to the plane of the

glenoid face. Make sure that the proximal

handle of the instrument is not tilted

superiorly. The guide pin should be inserted

either perpendicularly to the glenoid face

or with the distal tip of the guide pin in a

slightly superior direction. This ensures that

the glenosphere will either be perpendicular

to the plane of the glenoid face or have a

slight inferior tilt which may reduce the risk of

scapular notching.

Place the 2.5mm metaglene central guide pin

in the plate is central hole and drill it through

the far cortex using a power tool (Figure 25).

Remove the metaglene positioner, leaving the

guide pin in place (Figure 26).

Figure 25

Figure 26

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2322

Reaming the Glenoid Bone

Slide the 27mm glenoid resurfacing reamer

onto the central guide pin and ream either

manually or using a power tool. This reamer

prepares a smooth curved surface with the

same diameter as the metaglene (Figure 27).

Use the metaglene reamer carefully to avoid

any inadvertent fracturing of the glenoid,

especially if the glenoid is sclerotic. Make

sure the axillary nerve is protected. Initiate

and proceed with the reaming, turning at

low speed prior to engaging the glenoid.

It is useful to collect the osseous products

ofreamingandirrigateoftentomaximize

visualizationandtherebyensureoptimal

reaming. Be careful not to over ream and to

preserve the subchondral bone.

Ream the superior glenoid bone by hand,

using the manual 42mm glenoid reamer

(Figure 28). This step is necessary to avoid any

potential conflict between the glenosphere

and the superior area of the glenoid bone

(Figure 29).

Manual reaming should be carried out until

the central part of the manual reamer is in full

contact with the curved central glenoid surface.

Figure 27

Figure 28

Figure 29

Page 24: Delta XTEND Design Rationale

2524

Use the manual glenoid reamer to ream the

glenoid anteriorly, posteriorly and inferiorly

if necessary. A smooth surface without any

remaining cartilage should be obtained.

Check the adequacy of the reaming by

applying the glenoid reaming level checker on

the glenoid surface. No space (except if due

to bone erosion) should be seen between the

instrument and the glenoid surface (Figure 30).

Remove the resurfacing reamer, leaving the

metaglene central guide pin in place

(Figure 31).

Connect the cannulated stop drill to the power

source and drill the central hole over the guide

pin until full contact between the drill and

bone is obtained (Figure 32).

Remove the stop drill and the central guide pin.

Figure 30

Figure 32

Figure 31

Page 25: Delta XTEND Design Rationale

2524

Metaglene Implantation

Assemble the internal rod of the metaglene

holder in the metaglene holder main body.

Insert the metaglene holder hex tip in the final

metaglene implant central hole and tighten the

assembly. (Figure 33).

Place the metaglene on the glenoid bone

and ensure that the metaglene is fully

seated. Apply bone graft if necessary to

help fill surface irregularities between the

metaglene and the glenoid bone. Rotate the

metaglene so that the inferior screw can be

aimed toward the scapular neck. The vertical

metaglene marking should be aligned with

the scapular neck inferiorly and with the

base of the coracoid process superiorly (long

axis of the glenoid bone) (Figure 34). The

metaglene peg is 0.6mm larger in diameter

than the drill to enable a press fit. Gently

impact with a mallet in the proper orientation

for inferior screw placement and then remove

the metaglene holder.

Figure 33

Figure 34

Page 26: Delta XTEND Design Rationale

2726

Metaglene Superior-Inferior Cross Section Polyaxial Locking Screws

17°

±10°

Inferior and Superior MetagleneScrew Placement

Locking metaglene screws allow an angulation

of ± 10 degrees around the optimal 17

degrees screw positioning recommended by

Professor Grammont (Figure 35).

Place the 2.5mm drill guide in the metaglene

inferior hole. The drill guide can be angled

to ± 10 degrees but should always be seated

fully in the metaglene hole. Palpate the

scapular neck and aim into good bone. Using

the 2.5mm drill bit, start drilling through

the subchondral bone to aproximately 10 to

12mm deep (Figure 36). Then stop drilling and

push gently on the drill bit to make sure that

the drill is contained in the bone. Redirect and

redrill if uncontained. When a satisfactory

drilling direction has been obtained, drill and

push until the cortex is perforated.

Figure 35

Figure 36

Page 27: Delta XTEND Design Rationale

2726

The goal is to have a sufficiently long screw

inferiorly, usually 36mm or more. The length

of the screw is indicated on the drill bit by

laser markings (Figure 37). The screw depth

gauge can also be used to assess optimal

screw length.

Insert the 1.2mm guide pin through the

drill guide and then remove the drill guide

(Figure 38).

Slide the locking screw of the appropriate

length onto the guide pin. Check that the

internal tightening screw is unlocked (it should

rotate freely) (Figure 39).

Figure 38

Figure 39

Figure 37

Page 28: Delta XTEND Design Rationale

2928

Slide the locking screwdriver body on the

guide pin and insert the tip into the four slots

on the screw (Figure 40). Do not use the

internal screwdriver rod at this stage.

Note: Slide down the screwdriver sleeve

completely to protect the screw head.

Tighten the screw to compress the plate

(Figure 41a).

Remove the screw guide pin with the pin

extractor before final tightening to avoid

stripping, making sure that the internal locking

screw stays in place.

Repeat the same steps for the superior

locking screw.

Note: Use care to ensure that the

driver remains in axial alignment

with the screw so that the driver tip

remains fully engaged (Figure 41b).

Note: The tip of the screwdriver can

lose contact with the fins and does not

torque evenly on all sides if the protecting

sleeve is not used (Figure 41c).

Note: The protecting sleeve is not designed

to lock onto the screw. It must be held

in place with a finger during insertion.

Figure 41a

Figure 41b

Figure 41c

Figure 40

Page 29: Delta XTEND Design Rationale

2928

Figure 43

Figure 42

Drill the hole for the superior locking screw

anticipating exit through the far cortex using

the same methods as Figure 36 (inferior

screw placement) (Figure 42). The superior

screw should be directed at the base of the

coracoid process and should have an anterior

orientation to avoid the suprascapular nerve.

To obtain optimal compression of the

metaglene plate on bone, alternate tightening

of the superior and inferior locking screws

(Figure 43).

Note: Use care to ensure that the driver

remains in axial alignment with the screw so

that the driver tip remains fully engaged.

Page 30: Delta XTEND Design Rationale

3130

Metaglene Anterior-Posterior Cross Section Polyaxial Locking or Non-locking Screws

17°

±10°

The surgeon may use locking or non-locking

screws in the anterior or posterior holes. Both

types of screws will allow an angulation of

up to ± 10 degrees, but not in a direction

convergent to the central peg axis to avoid

conflict with the central peg (Figure 44).

Use the 2.5mm drill bit with the drill guide to

set the most appropriate angle for ensuring

that each screw is located in reliable bone

stock (Figure 45).

The preferred position is usually chosen by

palpating the anterior and posterior aspects

of the scapula as well as examining the X-rays

and CT scans. Drill in the direction of the

centralglenoidvaultinanattempttomaximize

the anterior and posterior compression screw

lengths, in a direction parallel to or divergent

from the central peg.

Figure 44

Figure 45

Anterior and Posterior MetagleneScrew Placement

Page 31: Delta XTEND Design Rationale

3130

Screw length is determined from the laser marks

on the drill bits or by using the depth gauge.

Slide the corresponding screws onto the guide

pin and tighten using the 3.5mm cannulated

hex screwdriver for non-locking screws or

the locking screwdriver for locking screws

(Figure 46).

Follow the same procedure for the posterior

screw, then alternately tighten both screws

until they are fully tightened.

Proceed with locking all variable angle

screws used. Place the locking screwdriver

main body in the head of the inferior screw.

Make sure that the screwdriver sleeve is in its

upper position and not in contact with the

screw head.

Slide the locking screwdriver internal rod into

the main body. The tip of the internal rod will

make contact with the screw head. Tighten it

fully, locking the screw in place by expanding

its head (Figure 47).

Note: After inserting all four screws, tighten

the locking screws with the internal rod

for the locking screwdriver. Pull the sleeve

up and off the screw head for this step.

Repeat the same steps to secure the superior

locking screw and anterior or posterior screws

if variable angle screws have been used.

The metaglene is left in place (Figure 48) and

the humeral preparation is then carried out.

Figure 46

Figure 48

Figure 47

Page 32: Delta XTEND Design Rationale

3332

Placement of the Proximal Humeral Reaming GuideCemented Monobloc Humeral Implants and Cementless Modular Humeral Implants

Select the appropriate proximal reaming

guidesize(Figure49).Forexample,ifa12mm

intramedullary reamer and a 12mm cutting

handle were previously used, select the 12mm

proximal reaming guide.

Slide and screw the internal rod of the reaming

guide holder into the holder main body. Then

slide the reaming guide into the reamer holder

and fasten the two parts together by firmly

tightening the upper round handle (Figure 50).

Push the holder horseshoe plate fully down

(Figure 51).

Slide the proximal reaming guide down

into the intramedullary canal, rotating it

if necessary to ensure that the horseshoe

plate sits flat on the bone resection surface

(Figure 52).

Drive the proximal reaming guide down until

complete contact between the metal block

and the resectioned bone surface is achieved

(Figure 53).

Unscrew the upper round handle of the holder

and remove the holder, leaving the proximal

reamer guide in place (Figure 54).

The subsequent surgical steps depend on

whether the humeral implant is cementless

or cemented. For cementless implants, see

pages 33-37. For cemented implants, see

pages 38-39.

Figure 52 Figure 53 Figure 54

Figure 49 Figure 50 Figure 51

Page 33: Delta XTEND Design Rationale

3332

MAkE SuRE yOu ARE uSInG tHE DEDICAtED InStRuMEntS

FOR CEMEntLESS MODuLAR IMPLAntS

Proximal Humeral ReamingCementless Modular Humeral Implants

Figure 55

Figure 56

Centered Adaptor Size1&2

DiskSize1

DiskSize2

Eccentric Adaptor Size1

Eccentric Adaptor S1DiskSize1

ADEQUATE BONECOVERAGE

Eccentric Adaptor S2DiskSize2

The cementless modular implant is designed

to allow the surgeon to place the epiphysis in

anatomic version and the stem in anatomic

version for an optimal press-fit.

Thesizeandtype(centeredoreccentric)of

modular epiphysis should be chosen to ensure

that the best possible coverage of the bone

resection surface is achieved.

First select the centered proximal modular

reamer adaptor, and place it on the reaming

guide’s angled pin.

Choosethemostappropriateepiphysissize

usingthemodularimplantsizerdisks,size1

or2.Thesizerdiskchosenshouldprovidethe

best coverage of the bone resection surface

without overhang (Figure 55).

If this does not provide a good fit with the

bone resection surface, switch the centered

proximal modular reamer adaptor for the

eccentricadaptorinsize1.Becarefulto

position the eccentricity so that it is posterior

and not anterior, double checking with the

markings (anterior and posterior) on the

adaptor.

Thenchecktheepiphysissizeagainwithsizer

disk 1. If the bone coverage is not sufficient,

useeccentricadaptorsize2andsizerdisksize2

(Figure 56).

Remember the final decision made, with

respect to the centered or eccentric epiphysis

andsize1or2,willdeterminereamerandfinal

implantsizes.

cementless modular

Page 34: Delta XTEND Design Rationale

3534

MAkE SuRE yOu ARE uSInG tHE DEDICAtED

InStRuMEntS FOR CEMEntLESS MODuLAR IMPLAntS

Proximal Humeral ReamingCementless Modular Humeral Implants

Figure 57

Figure 58

Removethesizerdisk,leavingtheproximal

modular reamer adaptor in place (Figure 57).

Select the appropriate proximal modular

reamerinsize1or2,accordingtotheresults

of the previous trials. Ream using a power

tool. Power reaming should always be carried

out carefully.

Complete reaming is achieved when the

external reamer flange is in full and complete

contact with the bone resection surface

(Figure 58).

When the proximal reaming has been

completed, first remove the reaming adaptor.

Then remove the reaming guide using the

reaming guide holder. If any bone remains in

the center of the epiphysis, remove it.

cementless modular

Page 35: Delta XTEND Design Rationale

3534

Goniometer

MAkE SuRE yOu ARE uSInG tHE DEDICAtED InStRuMEntS

FOR CEMEntLESS MODuLAR IMPLAntS

Distal Humeral BroachingCementless Modular Humeral Implants

Figure 59

Rocking Bar ContactContact

Figure 60

Thestemsizewillhavebeendetermined

from the previous intramedullary reaming. If

the 12mm intramedullary reamer has been

used, select the 12mm broach and attach it

to the broach handle. Make sure that the

goniometer is in place on the broach handle.

Drive the broach into place, carefully checking

that its anterior fin is aligned with the anterior

aspect of the bicipital groove. This will ensure

good distal stem orientation (anatomic version)

foranoptimizedpress-fit(Figure59).

Drive the broach down carefully, (to avoid any

cortical bone damage) until the rocking bar of

the broach handle is in full contact with bone,

both at the anterior and posterior aspects of

the resection surface (Figure 60).

If there is a cortical bone damage where the

rocking bar should contact bone, place the

broach handle plate on the resection.

Read the adjustment angle which is indicated

on the instrument.

cementless modular

Page 36: Delta XTEND Design Rationale

3736

MAkE SuRE yOu ARE uSInG tHE DEDICAtED

InStRuMEntS FOR CEMEntLESS MODuLAR IMPLAntS

Humeral Trial Stem and Epiphysis InsertionCementless Modular Humeral Implants

Figure 61

Figure 63

Figure 62

The trial modular epiphysis (centered or

eccentric,size1or2,dependingonthe

proximal reaming choices made) is placed on

the trial modular stem (diameter chosen during

distal reaming and broaching).

The epiphysis position corresponds to the

adjustment angle previously read on the

broach handle goniometer. For example, if 20

degrees right was read on the goniometer, the

epiphysis hole marked 20 degrees right should

be positioned in line with the stem orientation

peg (Figure 61).

Note: This angulation corresponds to the

difference between the version of the stem

(close to anatomical retroversion – 20 to 30

degrees) and the epiphysis version for a reverse

shoulder (close to 0 degrees retroversion).

No calculation is required: the

instrumentation has been designed to

provide direct measurement of this position

on the goniometer.

The two components are then screwed

together using the 3.5mm hex screwdriver

and the special locking wrench for modular

implants (Figure 62).

Both components are then mounted on the

humeral implant driver by pushing and then

releasing the blue button (Figure 63).

cementless modular

Page 37: Delta XTEND Design Rationale

3736

MAkE SuRE yOu ARE uSInG tHE DEDICAtED InStRuMEntS

FOR CEMEntLESS MODuLAR IMPLAntS

Humeral Trial Stem and Epiphysis InsertionCementless Modular Humeral Implants

Figure 64

The component is then driven down the

intramedullary canal, aligning the anterior fin

of the stem with the bicipital groove.

The implant orientation can also be checked

using the orientation pin placed in the implant

driver handle. The pin should be placed in the

same retroversion position used to position

the cutting guide, i.e. close to 0 degrees

retroversion. The orientation pin should then

be aligned with the forearm axis and the trial

implants driven down (Figure 64).

Impact the trial implant by gently tapping

in the implant driver handle and remove

the driver, leaving the trial implant in place

(Figure 65). The driver is detached by pushing

the blue button.

Figure 65

cementless modular

Page 38: Delta XTEND Design Rationale

3938

MAkE SuRE yOu ARE uSInG tHE DEDICAtED InStRuMEntS

FOR CEMEntED MOnOBLOC HuMERAL IMPLAntS

Proximal Humeral ReamingCemented Monobloc Humeral Implants

Figure 66

Figure 67

DiskSize1

Themonoblocimplantsizeshouldbechosen

to match the initial distal reaming diameter.

Choosethemostappropriateepiphysissize

byplacingamonoblocimplantsizerdiskin

size1or2ontheproximalreamingguide.

Themostappropriatesizewillbethesizerdisk

that provides the best possible coverage of the

bone resection surface (Figure 66).

Thesizechosen,epiphysissize1or2,will

determine proximal reamer and final

implantsizes.

Removethesizerdisk.

Select the appropriate proximal reamer for the

monoblocimplant,size1or2,fromtheresults

of the previous trials. Ream the metaphysis

using a power reamer (Figure 67).

Complete reaming is achieved when the

external reamer flange is in full and complete

contact with the bone resection surface.

When the proximal reaming has been

completed, remove the reaming guide using

the reaming guide holder.

cemented monobloc

Page 39: Delta XTEND Design Rationale

3938

MAkE SuRE yOu ARE uSInG tHE DEDICAtED InStRuMEntS

FOR CEMEntED MOnOBLOC HuMERAL IMPLAntS

Humeral Trial Implant InsertionCemented Monobloc Humeral Implants

Figure 68

Figure 69

Select the appropriate trial humeral implant.

For example, if the initial distal reaming was

carried out using the 12mm reamer and

proximal reaming was carried out using the

size1proximalreamer,selectmonobloc

humeral trial epiphysis number 1 with

diameter 12mm.

Mount the trial implant on the humeral

implant driver and drive it down the

intramedullary canal.

The implant orientation should be checked

using the orientation pin placed in the implant

driver handle. The pin should be placed in the

same retroversion position used to position

the cutting guide, i.e. close to 0 to 10 degrees

retroversion. The orientation pin should then

be aligned with the forearm axis and the trial

implants driven down (Figure 68).

Impact the trial implant by gently tapping

the implant driver handle and remove the

driver, leaving the trial implant in place

(Figure 69). The driver is detached by

pushing on the blue button.

ForearmAxis

1 to 10°Retroversion

cemented monobloc

Page 40: Delta XTEND Design Rationale

4140

Figure 71

Figure 72

Glenosphere Trial Placement

Figure 70

The glenosphere implants are available in

two diameters, 38 and 42mm, and are either

standard or eccentric spheres.

An overlap of 3 to 5mm is recommended to

avoid conflict with the scapular neck (Figure 70).

Depending on the shape of the scapular neck,

this overlap can be achieved by using a standard

metaglene just by lowering the metaglene.

The 42mm glenosphere is recommended if

thesizeofthejointallows(increasesboththe

overlap and the range of motion). The eccentric

glenospheres are recommended for more

transverse scapular necks.

Fit the appropriate trial glenosphere (38mm

or 42mm, centered or eccentric) to the the

metaglene using the metaglene holder

(Figure 71).Thetrialglenosphereutilizesan

interference fit to make the connection with

the metaglene.

For eccentric glenospheres, the vertical

laser mark on the trial glenosphere should

be aligned with the base of the coracoid

superiorly and the scapular neck inferiorly

(Figures 71 and 72).

The arrow indicates the position of the

eccentricity and should be positioned inferiorly,

aligned with the scapular neck (Figures 72).

Note: If it is difficult to place the glenosphere

trial, then check to ensure the superior portion

of the glenoid has been reamed adequately

and that there is no soft tissue in the way.

Page 41: Delta XTEND Design Rationale

4140

Cup Trials and Trial Reduction

Figure 73

Place the humeral trial cup (38 or 42mm

dependingontheglenospheresize),with

+3mm of lateral offset, in the trial epiphysis

(Figure 73). The shoulder should then be

reduced with longitudinal traction and

assessed for a full range of motion (Figure 74).

Figure 74

Page 42: Delta XTEND Design Rationale

4342

Joint Tensioning and Stability Assessment

Jointtensioningandstabilityassessment

should be performed with particular care,

using the following guidelines:

• Tensionwithintheconjoinedtendonshould

be noticeably increased and detectable by

palpation.

• Withthearminaneutralposition,apply

a longitudinal traction force to the arm

while observing the movement of the

shoulder with respect to the entire shoulder

girdle as well as the trial prosthetic joint.

Tension is appropriate if, in response to the

longitudinal traction, the entire shoulder

moves before detectable separation of the

trial prosthetic surfaces.

• Externalrotationmayappropriately

demonstrate slight gapping between the

glenosphere and articular surface (2 to

3mm maximum).

• Positioningahandorfistneartheaxilla

to serve as a fulcrum, further adduct the

arm and look for undesirable tendencies to

sublux or dislocate laterally (a small opening

of 2 to 3mm is acceptable). Estimate the

maximum forward elevation.14

• Assessstabilityat90degrees,abduction

with the humerus in neutral, maximum

internal and maximum external rotation.

Estimate the maximum forward elevation.14

If instability can be demonstrated, it is critical

to identify the cause and develop a solution

to the problem. Make sure that the implants

have been positioned correctly with respect

totheboneandtoeachother.Overcome

any conflicts between the proximal humeral

component and soft tissues or osseous

structures that surround the glenosphere

(e.g. non-union of the greater tuberosity)

by excision of the conflicting elements.

Inadequate tensioning may be overcome using:

• Athickercup(+6mmor+9mm)

• A42mmglenosphere

• Amodularhumerallengthenerorretentive

cups in more extreme cases

If unable to reduce the joint, the options

include additional soft tissue releases and

lowering the level of humeral resection.

When the trials are satisfactory, the trial

glenosphere should be removed using the

extraction T-Handle so that final implant

fixation can be performed.

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4342

Definitive Glenosphere Fixation Standard Glenosphere

Figure 75

Figure 76

Insert the 1.5mm guide pin through the

central hole of the metaglene.

Engage the 3.5mm cannulated hex screwdriver

in the final glenosphere. Slide the glenosphere

on the 1.5mm guide pin until it is in contact

with the metaglene (Figure 75). Proper

alignment between the glenosphere and

metaglene is absolutely essential to avoid cross

threading between the components.

If the glenosphere seems difficult to thread

onto the metaglene, do not force engagement

but re-align the components. If necessary,

remove the inferior retractor or improve the

capsular release. It is also important to check

that there is no soft tissue between the

metaglene and glenosphere.

When accurate thread engagement is obtained

and after a few turns, remove the guide pin to

avoid stripping in the screwdriver.

Standard glenosphere

Tighten until the scapula begins to rotate

slightly in a clockwise direction, meaning that

the glenoid bearing is closing on the taper of

the metaglene.

Gently tap on the glenosphere with the

glenosphere impactor a minimum of three times

(Figure 76). Tighten the glenosphere central

screw again. Care should be taken to ensure

that the glenoid bearing is fully locked onto the

metaglene. The gentle hammering procedure

and screw tightening can be repeated, if

necessary, until the screw is fully tightened.

Note: Glenosphere will sit about 1mm proud

on the metaglene with consistent uniformity

Page 44: Delta XTEND Design Rationale

4544

Definitive Glenosphere FixationEccentric Glenosphere

Figure 78

Figure 79

Figure 77

Eccentric glenosphere

Slide the glenosphere orientation guide onto

the screwdriver core and position it in the

eccentric glenosphere central slot (Figure 77).

The arrow marked on the orientation guide

should be aligned with the base of the

coracoid process to position the eccentricity

correctly. Maintain the orientation guide in the

required position and screw the glenosphere

into place using the screwdriver until the

glenoid bearing closes on the taper of the

metaglene (Figure 78).

Obtainfurtherimpactionofthejunction

by gently hammering the glenosphere with

the glenosphere impactor a minimum of

three times (Figure 79). Then tighten the

glenosphere central screw again. Care should

be taken to ensure that the glenoid bearing is

fully locked onto the metaglene.

Repeat if necessary until screw is fully tightened.

Note: Glenosphere will sit about 1mm proud

on the metaglene with consistent uniformity

Page 45: Delta XTEND Design Rationale

4544

Definitive Glenosphere FixationGlenosphere Removal

Figure 80

If it is necessary to remove the glenosphere

(revisionorintra-operativesizemodification),

the glenosphere/metaglene junction can be

disassembled by unscrewing the glenosphere

central screw using the 3.5mm hex head

screwdriver (Figure 80). This operation

should be done smoothly to avoid central

screw damage.

Page 46: Delta XTEND Design Rationale

4746

Definitive Humeral Implants InsertionCementless Modular Humeral Implants

Figure 81

Figure 82

Figure 83

Remove the trial cups and trial implants using

the humeral implant driver.

Select the appropriate final modular humeral

implants that correspond to the trial implants.

Place the final modular epiphysis on the final

modular stem in the same rotational position

used for the trial implants (Figure 81).

Screw the final modular epiphysis together

with the final humeral stem, using the 3.5mm

hex screwdriver and the special locking wrench

for modular implants (Figure 82).

Both components should then be mounted on

the humeral implant driver and driven down

the intramedullary canal, aligning the anterior

fin of the stem with the bicipital groove

(Figure 83). The epiphysis should be aligned

with the edge of the bone resection.

MAkE SuRE yOu ARE uSInG tHE DEDICAtED

InStRuMEntS FOR CEMEntLESS MODuLAR IMPLAntS

cementless modular

Page 47: Delta XTEND Design Rationale

4746

Remove the trial cups and trial implants

using the humeral implant driver. Select the

appropriate final monobloc humeral implant

corresponding to the trial implant.

Inserting cement restrictor

Determinethetrialsizeofthecementrestrictor

and gauge the implantation depth (Figure 84).

Check that the trial restrictor is firmly seated in

the canal, then remove trial.

Use pulsatile lavage and a nylon brush to clear

the humeral canal of debris and to open the

interstices of the bone ready for the cement.

Place the definitive cement restrictor at the

appropriate depth and check that it is firmly

seated in the canal.

Pass non-absorbable sutures such as DePuy

MitekOrthocord® Suture, through the proximal

humerus near the lesser tuberosity to enable

secure re-attachment of the subscapularis (if

possible). Avoid re-attachment if unable to

externallyrotatethehumerustozerodegrees.

Irrigate the canal, during a secondary cleaning,

using pulsatile lavage to remove loose bone

remnants and marrow. Some surgeons may

wishtoinsertaone-inchgauzepre-soaked

in an epinephrine (1:1,000,000 solution) or

hydrogen peroxide solution to aid haemostasis

and the drying of the humeral canal (Figure 85).

Cement in the humeral implant as directed.

MAkE SuRE yOu ARE uSInG tHE DEDICAtED InStRuMEntS

FOR CEMEntED MOnOBLOC HuMERAL IMPLAntS

cemented monobloc

Definitive Humeral Implant InsertionCemented Monobloc Humeral Implants

Figure 84

Figure 85

Page 48: Delta XTEND Design Rationale

4948

Implant insertion

Introduce the final implant in the chosen

version in line with the long axis of the

humerus, using the humeral implant driver

(0 degrees to 10 degrees of retroversion)

(Figure 86).

Excess cement will extrude from the canal

and should be removed before curing is

complete. Inspect the exposed portion of

the humeral component for cement and

remove as necessary. Maintain pressure on

thedriveruntilthecementisfullypolymerized

to avoid micromotion that could cause crack

propagation. Remove the lap sponge dam and

irrigate the wound thoroughly. Place the trial

articular surface and reduce the joint. Confirm

stability and dislocate the humerus.

Note: Retroversion is calculated with

reference to the forearm axis (0 to 10 degrees)

Definitive Humeral Implant Insertion

Figure 86

0° to 10° Retroversion

Forearm Axis

Page 49: Delta XTEND Design Rationale

4948

Definitive Humeral Implant Insertion

Figure 87

Figure 88

Final cup fixation

Impact the final humeral cup using the cup

impactor (Figure 87).

Step 1

Insert the polyethylene humeral cup by hand.

Turn it 180 degrees in the epiphysis to make

sure that it is evenly seated and that there is no

soft tissue, cement or fluid interfering with the

cup to epiphysis connection (Figure 88).

Page 50: Delta XTEND Design Rationale

5150

Definitive Humeral Implant Insertion

Figure 89

Figure 90

Step 2

Onceyouareconfidentthatyouhave

perfect aligment, impact the humeral

cup at a 90 degree angle to the epiphysis

(Figure 89). Make sure the arm is fully

supported to ensure full impaction.

Step 3

Oncefullyseatedtherewillbeapproximately

a 1mm gap between the lip of the cup and

the epiphysis. The 1mm gap will aid future

revisions if necessary. The cup should not

move or shift when touched. If this is the

case, realign the implant and repeat the

impaction steps (Figure 90).

When a humeral spacer is needed, impact

it first on the epiphysis and then impact the

final cup on it.

Note: All junction surfaces between the

implant components should be clean and

free of any tissue before impaction.

Reduce the joint and carry out a final

assessment of joint stability and range

of motion.

Impact Direction

90° from Surface Plane

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5150

1

1

2

2

33

4

4

Cases of proximal bone loss will be treated

using cemented monobloc humeral implants

to avoid any risk of component dissociation.

Long monobloc stems may be required in

some cases.

The preparation of the humeral canal for long

stems uses the same technique described for

standard stems, with the exception of the

procedure for reaming the humeral canal,

which differs in this respect: the entire length

of the cutting flutes should be passed down

the intramedullary canal instead of being

stopped at the mark (Figure 91).

A positioning jig is available to hold both the

trial long stem and the final implant in place at

the correct height and in retroversion.

Tighten the fin clamp on the humeral

shaft first using the 3.5mm screwdriver

(Figure 92).

Place the fin clamp over the vertical

height gauge of the humeral shaft clamp

and secure the fin clamp to the central

hole in the anterior fin of the prosthesis.

Place the prosthesis at the

appropriate height.

Tighten the fin clamp to secure it to the

vertical height gauge.

The jig can be left in place while testing

motion, and used to place the final stem at the

height determined during the trials.

Cases of Proximal Humeral Bone Loss

Figure 91

Figure 92

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5352

Note that aligning the retroversion guide pin

with the forearm places the implant in 30

degree retroversion. Readjust the retroversion

of the jig to match 0 to 10 degrees

retroversion as used for the reverse shoulder

prosthesis (Figure 93).

Height lines are also present on the trial

long stems to enable better marking of the

appropriate prosthesis height. Determine

an appropriate mark, then place the trial

stem beside the final implant and mark the

corresponding height (Figure 94). Use that mark

to cement the stems at the proper height.

Sutures through the stem fin holes (smooth

edges) can be used to reconstruct the

proximal humerus.

Note: This will have to be done by estimating

when you are between 0 to 10 degrees.

20˚- 30˚

Trial Implant Definitive Implant

Corresponds to Middle Suture Hole

on Definitive Implant

Cases of Proximal Humeral Bone Loss

Figure 93

Figure 94

Page 53: Delta XTEND Design Rationale

5352

When revision of a reverse shoulder is

required due to glenoid loosening, or when

glenoid bone stock is insufficient to fix a

metaglene securely, the reverse shoulder

can be converted to an hemi-prothesis as a

salvage procedure. Specific hemi-heads with

lateral head coverage, Delta XTEND CTA

heads, are available. This is also indicated for

intraoperative glenoid fracture.

Remove the glenosphere using the 3.5mm

hex head screwdriver. Remove the metaglene

locking screws using the locking screwdriver

and the non-locking screw using the 3.5mm

hex head screwdriver. Remove the metaglene

using the extraction T-Handle and remove the

humeral cup using the cup extraction clamp

(Figure 95).

Place the Delta XTEND CTA head reamer guide

in the epiphysis (Figure 96). Align the anterior

and posterior slot of the reaming guide with

the slots of the epiphysis and impact the

reaming guide gently with a mallet.

Assemble the Delta XTEND CTA head reamer

with the T-Handle. Ream the area around the

epiphysis manually (Figure 97). If the Delta

XTEND CTA trial head does not obtain perfect

seating on the epiphysis, finish the preparation

using a rongeur.

ChoosetheappropriatesizeofDeltaXTEND

CTA head using the trial heads.

Gently impact the appropriate final head using

the humeral head impactor (Figure 98). Make

sure that the junction surfaces between the

components are clean and free of any soft

tissue before impaction. The retroversion

of the Delta XTEND CTA head should be

chosen to match the patient’s anatomy. This

requires that the head is placed in the proper

orientation before impacting.

Revision to Hemi-Arthroplasty

Figure 95

Figure 98Figure 97

Figure 96

Page 54: Delta XTEND Design Rationale

5554

Post-Operative Management

2. Late phase (after 6 weeks)

After the sixth week, active strengthening movements

may gradually be added to the program. These

exercises, which closely follow everyday activities, are

to be performed in a sitting or standing position using

conventional methods, with isometric exercises and

resistance movements becoming increasingly important.

Aseriesofexercisesforrhythmicstabilizationofthe

upper arm as well as eccentric work on lowering the arms

complete the strengthening of the muscles. Physiotherapy

may be performed over a period of at least six months.

1. Early phase (0 to 6 weeks)

Two days after the operation, the patient may be mobile.

This early phase is dedicated to gentle and gradual

recovery of the passive range of shoulder motion:

abduction of the scapula, anterior elevation and medial

and lateral rotation. An abduction cushion may be used

to relieve pressure on the deltoid. Physiotherapy is mainly

performed with the patient supine, passive and with

both hands holding a bar that is manipulated by the

contralateral hand, as described by Neer. The patient is

encouraged to use the affected arm post-operatively to

eat and write, but should not use it to push behind the

back or to raise themselves from the sitting position to

the standing position. In conjunction with these exercises

for scapulohumeral recovery, it is important to strengthen

muscle connection with the scapula in order to facilitate

muscle and implant function. Passive exercise in a

swimming pool is recommended as soon as scars begin

to form. More caution is required to protect the deltoid

muscle from excessive demand if a superior approach has

been used for surgery.

Post- operative physiotherapy is an important factor in the outcome of this procedure, since stability and mobility now

depend on the deltoid alone. The physiotherapy program, which should be planned to suit each individual patient, consists

of two phases:

Page 55: Delta XTEND Design Rationale

5554

STANDARDIMPLANTCODES

Cemented Monobloc Humeral Implants 1307-08-100 MonoblocHumeralCementedStemEpiphysisSize18mmStandard

1307-10-100 MonoblocHumeralCementedStemEpiphysisSize110mmStandard

1307-12-100 MonoblocHumeralCementedStemEpiphysisSize112mmStandard

1307-14-100 Monobloc HumeralCementedStemEpiphysisSize114mmStandard

1307-10-200 MonoblocHumeralCementedStemEpiphysisSize210mmStandard

1307-12-200 MonoblocHumeralCementedStemEpiphysisSize212mmStandard

1307-14-200 MonoblocHumeralCementedStemEpiphysisSize214mmStandard

Cementless Modular Humeral Implants 1307-10-000 Modular Humeral Stem 10mm HA

1307-12-000 Modular Humeral Stem 12mm HA

1307-14-000 Modular Humeral Stem 14mm HA

1307-16-000 Modular Humeral Stem 16mm HA

1307-20-101 ModularCenteredEpiphysisSize1HA

1307-20-102 ModularEccentricEpiphysisSize1LeftHA

1307-20-103 ModularEccentricEpiphysisSize1RightHA

1307-20-201 ModularCenteredEpiphysisSize2HA

1307-20-202 ModularEccentricEpiphysisSize2LeftHA

1307-20-203 ModularEccentricEpiphysisSize2RightHA

Polyethylene Cup and Humeral Spacer 1307-38-203 Standard Humeral PE Cup 38mm +3mm

1307-38-206 Standard Humeral PE Cup 38mm +6mm

1307-38-209 Standard Humeral PE Cup 38mm +9mm

1307-42-203 Standard Humeral PE Cup 42mm +3mm

1307-42-206 Standard Humeral PE Cup 42mm +6mm

1307-42-209 Standard Humeral PE Cup 42mm +9mm

1307-38-106 Retentive Humeral PE Cup 38mm +6mm

1307-42-106 Retentaive Humeral PE Cup 42mm +6mm

1307-30-009 Humeral Spacer +9mm

High Mobility Cups

1307-38-703 High Mobility Premieron™ X-Linked PE Humeral Cup Diameter 38mm +3mm

1307-38-706 High Mobility Premieron X-Linked PE Humeral Cup Diameter 38mm +6mm

1307-38-709 High Mobility Premieron X-Linked PE Humeral Cup Diameter 38mm +9mm

1307-42-703 High Mobility Premieron X-Linked PE Humeral Cup Diameter 42mm +3mm

1307-42-706 High Mobility Premieron X-Linked PE Humeral Cup Diameter 42mm +6mm

1307-42-709 High Mobility Premieron X-Linked PE Humeral Cup Diameter 42mm +9mm

Ordering InformationImplants

Centered

Eccentric

Page 56: Delta XTEND Design Rationale

5756

Glenoid Implants 1307-60-038 Eccentric Glenosphere 38mm

1307-60-042 Eccentric Glenosphere 42mm

1307-60-138 Standard Glenosphere 38mm

1307-60-142 Standard Glenosphere 42mm

1307-60-000 Metaglene

1307-70-018 Non Locking Metaglene Screw 4.5mm x 18mm

1307-70-024 Non Locking Metaglene Screw 4.5mm x 24mm

1307-70-030 Non Locking Metaglene Screw 4.5mm x 30mm

1307-70-036 Non Locking Metaglene Screw 4.5mm x 36mm

1307-70-042 Non Locking Metaglene Screw 4.5mm x 42mm

1307-90-024 Locking Metaglene Screw 4.5mm x 24mm

1307-90-030 Locking Metaglene Screw 4.5mm x 30mm

1307-90-036 Locking Metaglene Screw 4.5mm x 36mm

1307-90-042 Locking Metaglene Screw 4.5mm x 42mm

1307-90-048 Locking Metaglene Screw 4.5mm x 48mm

REVISIONIMPLANTCODES

Cemented Monobloc Long Stems 1307-08-110 MonoblocHumeralCementedStemEpiphysisSize18mmLong

1307-10-110 MonoblocHumeralCementedStemEpiphysisSize110mm Long

1307-12-110 MonoblocHumeralCementedStemEpiphysisSize112mmLong

1307-14-110 MonoblocHumeralCementedStemEpiphysisSize114mmLong

1307-10-210 MonoblocHumeralCementedStemEpiphysisSize210mmLong

1307-12-210 MonoblocHumeralCementedStemEpiphysisSize212mmLong

1307-14-210 MonoblocHumeralCementedStemEpiphysisSize214mmLong

CTA Heads 1307-48-021 Delta XTEND CTA Head 48mm x 21mm

1307-48-026 Delta XTEND CTA Head 48mm x 26mm

1307-52-021 Delta XTEND CTA Head 52mm x 21mm

1307-52-026 Delta XTEND CTA Head 52mm x 26mm

Ordering InformationImplants

Standard Eccentric

Page 57: Delta XTEND Design Rationale

5756

Ordering InformationStem Sizes

Length of Cemented Monobloc Humeral Implants

Designation Cat Number Under Epiphysis Total Length

Monobloc Hum Cemented Epiphysis 1 8 Std 1307-08-100 105mm 132mm

Monobloc Hum Cemented Epiphysis 1 10 Std 1307-10-100 110mm 137mm

Monobloc Hum Cemented Epiphysis 1 12 Std 1307-12-100 117mm 144mm

Monobloc Hum Cemented Epiphysis 1 14 Std 1307-14-100 126mm 153mm

Monobloc Hum Cemented Epiphysis 2 10 Std 1307-10-200 110mm 137mm

Monobloc Hum Cemented Epiphysis 2 12 Std 1307-12-200 117mm 145mm

Monobloc Hum Cemented Epiphysis 2 14 Std 1307-14-200 126mm 154mm

Monobloc Hum Cemented Epiphysis 1 8 Long 1307-08-110 170mm 197mm

Monobloc Hum Cemented Epiphysis 1 10 Long 1307-10-110 180mm 207mm

Monobloc Hum Cemented Epiphysis 1 12 Long 1307-12-110 182mm 209mm

Monobloc Hum Cemented Epiphysis 1 14 Long 1307-14-110 196mm 223mm

Monobloc Hum Cemented Epiphysis 2 10 Long 1307-10-210 180mm 207mm

Monobloc Hum Cemented Epiphysis 2 12 Long 1307-12-210 182mm 210mm

Monobloc Hum Cemented Epiphysis 2 14 Long 1307-14-210 196mm 224mm

Length of Cementless Modular Humeral Implants

Size Under Epiphysis Total Length Epiphysis Options

10mm 110mm 138mm Epi 1 Cent Ecc-L Ecc-R

Epi 2 Cent Ecc-L Ecc-R

12mm 117mm 145mm Epi 1 Cent Ecc-L Ecc-R

Epi 2 Cent Ecc-L Ecc-R

14mm 126mm 153mm Epi 1 Cent Ecc-L Ecc-R

Epi 2 Cent Ecc-L Ecc-R

16mm 135mm 162mm Epi 1 Cent Ecc-L Ecc-R

Epi 2 Cent Ecc-L Ecc-R

Mo

du

lar

Un

der

Ep

iph

ysis

Mo

no

blo

c

Un

der

Ep

iph

ysis

Mo

du

lar

Tota

l Len

gth

Mo

no

blo

c

Tota

l Len

gth

Page 58: Delta XTEND Design Rationale

5958

1

2

9

34

5

6

7

8

10 11 12

1

2

9

3

4

5

6 7

8

101112

13 14

5

4

3

2

1

6

8

9

7

2307-99-005 Delta XTEND Humeral 1 Case Complete

1 2128-61-070 Standard Hudson T-handle

2 1524-00-000 HudsonAOConverter

3 2128-01-006 Medulary Canal Reamer 6mm

4 2128-01-008 Medulary Canal Reamer 8mm

5 2128-01-010 Medulary Canal Reamer 10mm

6 2128-01-012 Medulary Canal Reamer 12mm

7 2128-01-014 Medulary Canal Reamer 14mm

8 2128-01-016 Medulary Canal Reamer 16mm

9 2001-65-000 Humeral Head Impactor

10 2001-66-000 Head Impactor Tip

11 2307-67-000 Humeral Cup Impactor Tip

12 2307-68-000 Spacer Impactor Tip

1 2307-70-008 Handle for Cutting Guide 8mm

2 2307-70-010 Handle for Cutting Guide 10mm

3 2307-70-012 Handle for Cutting Guide 12mm

4 2307-70-014 Handle for Cutting Guide 14mm

5 2307-70-016 Handle for Cutting Guide 16mm

6 2307-72-003 Delto-pectoral Cutting Guide

7 2307-72-004 Delto-pectoral Cutting Plate

8 2307-73-003 Superior-lateral Cutting Guide

9 2307-73-004 Superior-lateral Cutting Plate

10 2307-99-004 Pin Extractor

11 2307-71-000 OrientationPin2.5mmx200mm

12 9399-99-315 Drill Bit 3.2mm

13 2490-95-000 Cutting Guide Fixation Pin 3.2mm x 2

14 2490-95-000 Cutting Guide Fixation Pin 3.2mm x 2

1 2307-74-008 Proximal Reaming Guide 8mm

2 2307-74-010 Proximal Reaming Guide 10mm

3 2307-74-012 Proximal Reaming Guide 12mm

4 2307-74-014 Proximal Reaming Guide 14mm

5 2307-74-016 Proximal Reaming Guide 16mm

6 2307-83-000 Humeral Implant Driver

7 2307-85-000 Humeral Resection Protection Plate

8 2307-74-001 Proximal Reaming Guide Holder

9 2307-74-002 Proximal Reaming Guide Holder Internal Rod

Ordering InformationHumeral Instruments

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5958

1

2

9

3

4

5 6

7 8

10 11 12

13 14 15

16 17 18

20 21

22 23 24

25 26 27

19

Monobloc Only Monobloc Only

1 2

8

3 4

5 6 710

9

11

Modular Only

6

5

4

3

1

7

89

10

11 12

13

14

2

2307-99-006 Delta XTEND Humeral 2 Case Complete

1 2307-08-100 MonoblocHumeralTrialEpiphysisSize18mmStandard

2 2307-10-100 MonoblocHumeralTrialEpiphysisSize110mmStandard

3 2307-12-100 MonoblocHumeralTrialEpiphysisSize112mmStandard

4 2307-14-100 MonoblocHumeralTrialEpiphysisSize114mmStandard

5 2307-10-200 MonoblocHumeralTrialEpiphysisSize210mmStandard

6 2307-12-200 MonoblocHumeralTrialEpiphysisSize212mmStandard

7 2307-14-200 MonoblocHumeralTrialEpiphysisSize214mmStandard

8 2307-80-003 MonoblocEpiphysealDiskSize1

9 2307-80-004 MonoblocEpiphysealDiskSize2

10 2307-81-003 MonoblocProximalReamerEpiphysisSize1

11 2307-81-004 MonoblocProximalReamerEpiphysisSize2

1 2307-10-001 Modular Humeral Stem Trial 10mm

2 2307-12-001 Modular Humeral Stem Trial 12mm

3 2307-14-001 Modular Humeral Stem Trial 14mm

4 2307-16-001 Modular Humeral Stem Trial 16mm

5 2307-84-001 Modular Implant Locking Wrench 10-12mm

6 2307-84-002 Modular Implant Locking Wrench 14-16mm

7 2307-20-102 ModularEccentricTrialEpiphysisSize1Left

8 2307-20-101 ModularCentredTrialEpiphysisSize1

9 2307-20-103 ModularEccentricTrialEpiphysisSize1Right

10 2307-20-202 ModularEccentricTrialEpiphysisSize2Left

11 2307-20-201 ModularCentredTrialEpiphysisSize2

12 2307-20-203 ModularEccentricTrialEpiphysisSize2Right

13 2307-38-403 Standard Humeral Cup Trial 38mm +3mm

14 2307-38-406 Standard Humeral Cup Trial 38mm +6mm

15 2307-38-409 Standard Humeral Cup Trial 38mm +9mm

16 2307-42-403 Standard Humeral Cup Trial 42mm +3mm

17 2307-42-406 Standard Humeral Cup Trial 42mm +6mm

18 2307-42-409 Standard Humeral Cup Trial 42mm +9mm

19 2307-30-009 Humeral Spacer Trial +9mm

20 2307-38-506 Retentive Humeral Cup Trial 38mm +6mm

21 2307-42-506 Retentive Humeral Cup Trial 42mm +6mm

22 2307-38-303 High Mobility Humeral Cup Trial 38mm +3mm

23 2307-38-306 High Mobility Humeral Cup Trial 38mm +6mm

24 2307-38-309 High Mobility Humeral Cup Trial 38mm +9mm

25 2307-42-303 High Mobility Humeral Cup Trial 42mm +3mm

26 2307-42-306 High Mobility Humeral Cup Trial 42mm +6mm

27 2307-42-309 High Mobility Humeral Cup Trial 42mm +9mm

1 2307-01-030 Broach Handle

2 2307-01-031 Goniometer

3 2307-79-010 Humeral Broach 10mm

4 2307-79-012 Humeral Broach 12mm

5 2307-79-014 Humeral Broach 14mm

6 2307-79-016 Humeral Broach 16mm

7 2307-01-032 Broach Handle Plate

8 2307-76-002 EccentricProximalReamingAdaptorSize2

9 2307-76-000 Centred Proximal Reaming Adaptor

10 2307-76-001 EccentricProximalReamingAdaptorSize1

11 2307-77-004 EpiphysealDiskforModularImplantSize2

12 2307-77-003 EpiphysealDiskforModularImplantSize1

13 2307-78-003 ProximalReamerforModularImplantSize1

14 2307-78-004 ProximalReamerforModularImplantSize2

Ordering InformationHumeral Instruments

Page 60: Delta XTEND Design Rationale

6160 6160

5

4

3

21

6

7

8

9

5

4

32

1

6

7

8

9 10

11

12 13

14

Ordering InformationGlenoid Instruments

2307-99-007 Delta XTEND Glenoid Case Complete

1 2307-86-002 Forked Retractor

2 2307-87-004 Metaglene Central Guide Pin 2.5mm x 2

3 2307-87-005 Metaglene Holder

4 2307-87-002 Metaglene Holder Internal Rod

5 2307-87-003 Metaglene Positioning Plate

6 2307-88-027 Glenoid Resurfacing Reamer 27mm

7 2307-88-242 Glenoid Manual Reamer 42mm

8 2307-88-300 Glenoid Reaming Level Checker

9 2307-89-000 Glenoid Cannulated Stop Drill 7.5mm

1 2307-90-005 Drill Bit 2.5mm x 120mm x 2

2 2307-90-004 Screw Guide Pin 1.2mm x 150mm x 5

3 2307-96-000 Glenosphere Guide Pin 1.5mm x 300mm

4 2307-91-001 Screw Depth Gauge

5 2307-93-000 3.5mm Cannulated Hex Screwdriver

6 2307-92-003 Locking Screwdriver

7 2307-92-004 Locking Screwdriver Internal Rod

8 2307-90-003 Glenoid Drill Guide 2.5mm

9 2307-60-038 Eccentric Glenosphere Trial 38mm

10 2307-60-138 Standard Glenosphere Trial 38mm

11 2307-99-002 Extraction T-handle

12 2307-60-042 Eccentric Glenosphere Trial 42mm

13 2307-60-142 Standard Glenosphere Trial 42mm

14 2307-95-000 GlenosphereOrientationGuide

Page 61: Delta XTEND Design Rationale

6160 6160

5

4

2

3

1

6

7

5

4

3

2

1

6

7

8 9

10 11

12

2307-99-008 Delta XTEND Revision Case Complete

1 2307-99-001 Humeral Cup Extraction Clamp

2 ITH003 Stem Impactor/Extractor

3 2307-82-001 Delta XTEND CTA Head Reamer Guide

4 2307-82-003 Delta XTEND CTA Head Reamer

5 ETH001 Standard Humeral Prosthesis Extractor

6 MAI001 Slap Hammer

7 MDE001 Extraction Rod

1 2307-08-110 MonoblocHumeralTrialEpiphysisSize18mmLong

2 2307-10-110 MonoblocHumeralTrialEpiphysisSize110mmLong

3 2307-12-110 MonoblocHumeralTrialEpiphysisSize112mmLong

4 2307-14-110 MonoblocHumeralTrialEpiphysisSize114mmLong

5 2307-10-210 MonoblocHumeralTrialEpiphysisSize210mmLong

6 2307-12-210 MonoblocHumeralTrialEpiphysisSize212mmLong

7 2307-14-210 MonoblocHumeralTrialEpiphysisSize214mmLong

8 2307-48-121 Delta XTEND CTA Trial Head 48mm x 21mm

9 2307-48-126 Delta XTEND CTA Trial Head 48mm x 26mm

10 2307-52-121 Delta XTEND CTA Trial Head 52mm x 21mm

11 2307-52-126 Delta XTEND CTA Trial Head 52mm x 26mm

12 2128-01-035 Global®FXPositioningJig

Ordering InformationRevision Instruments

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6362

This Essential Product Information does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessary information.

INDICATIONS Delta XTEND Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint.

The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant. The Delta XTEND CTA hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision of a previously failed Delta XTEND Reverse Shoulder.

The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. The modular humeral stem and epiphysis components are HA coated and are intended for cementless use. All other components are for cemented use only.

CONTRAINDICATIONS Shoulder joint replacements may be contraindicated where the patient is overweight, where there is infection, poor bone stock, severe deformity, drug abuse, overactivity, tumor, mental incapacity, muscle, nerve or vascular disease.

WARNINGS AND PRECAUTIONS The following conditions tend to adversely affect the fixation of the shoulder replacement implants:

1. Marked osteoporosis or poor bone stock,

2. Metabolic disorders or systemic pharmacological treatments leading to progressive deterioration of solid bone support for the implant (e.g., diabetes mellitus, steroid therapies, immunosuppressive therapies, etc.),

3. History of general or local infections,

4. Severe deformities leading to impaired fixation or improper positioning of the implant;

5. Tumors of the supporting bone structures;

6. Allergic reactions to implant materials (e.g. bone cement, metal, polyethylene);

7. Tissue reactions to implant corrosion or implant wear debris;

8. Disabilities of other joints.

ADVERSE EVENTS The following are the most frequent adverse events encountered after total or hemi-shoulder arthroplasty:

1. Changeinpositionoftheprosthesis,oftenrelatedtofactorslistedinWARNINGSANDPRECAUTIONS.

2. Early or late infection;

3. Earlyorlatelooseningoftheprostheticcomponent(s),oftenrelatedofactorslistedinWARNINGANDPRECAUTIONS;

4. Temporary inferior subluxation. Condition generally disappears as muscle tone is regained;

5. Cardiovascular disorders including venous thrombosis, pulmonary embolism and myocardial infarction;

6. Hematoma and/or delayed wound healing;

7. Pneumonia and/or atelectasis;

8. Subluxation or dislocation of the replaced joint.

Essential Product Information

Page 63: Delta XTEND Design Rationale

6362

Notes

Page 64: Delta XTEND Design Rationale

2M07100612-53-505 (Rev. 5)

Printed in USA.© 2010 DePuy Orthopaedics, Inc. All Rights Reserved.

References1. Neer, C.S. 2nd, et. al. “Cuff-Tear Arhtropathy.” Journal of Bone Joint Surgery 1983.

2. Broström, L.A., et. al. “The Kessel Prosthesis in Total Shoulder Arthroplasty. A five Year Experience”; Clinical Orthopaedics and Related Research 1992.

3. Grammont, P.M., et. al. “Delta Shoulder Prosthesis For Rotator Cuff Rupture.” Orthopaedics 1993.

4. Sirveaux,F.,et.al.“GrammontInvertedTotalShoulderArthroplastyintheTreatmentofGlenohumeralOsteoarthritisWithMassive Rupture of the Cuff. Results of a Multicenter Study of 80 Shoulders.” Journal of Bone Joint Surgery Br 2004.

5. De Wilde, L.F., et. al. “Shoulder Prosthesis Treating Cuff Tear Arthropathy: A Comparative Biomechanical Study.” Journal of Orthopedic Research 2004.

6. Boileau, P., et. al. “Grammont Reverse Prosthesis: Design Rationale and Biomechanics.” Journal Shoulder Elbow Surgery 2005.

7. Nyfeller, R.W., et. al. “Biomechanical Relevance of Glenoid Component Positioning in the Reverse Delta III Prosthesis.” Journal Shoulder Elbow Surgery 2005.

8. Middernacht, B., et. al., “Consequences of Scapular Anatomy for Reversed Total Shoulder Arthroplasty”, Clinical Orthopaedics and Related Research 2008.

9. Wirth, M.A., et. al. “Compaction Bone-Grafting in Prosthetic Shoulder Athroplasty.” Journal of Bone Joint Surgery 2007.

10. Head, W.C., et. al. “Titanium Alloy as a Material of Choice for Cementless Femoral Components in Total Hip Arthroplasty,” Clinical Orthopaedics and Related Research 1995.

11. Karelse, A.T., et. al., “Prosthetic Component Relationship of the Reverse Delta III Total Shoulder Prosthesis in the Transverse Plane of the Body”, Journal of Shoulder and Elbow Surgery 2008.

12.Collis,D.,et.al.“ComparisonofClinicalOutcomesinTotalHipArthroplastyUsingRoughandPolishedCementedStemswith Essentially the Same Geometry.” Journal of Bone and Joint Surgery.ORG,2002.

13. Data on file, DePuy France DHF, 2006.

14. Van Seymortier, P., et. al., “The Reverse Shoulder Prosthesis (Delta III) in Acute Shoulder Fractures: Technical Considerations with Respect to Stability”, Acta Orthopaedica Belgica 2006.

15.Fenlin,J.M.Jr.,“TotalGlenohumeralJointReplacement”,Orthopedic Clinics of North America 1975.

16.Wirth,M.A.,Klotz,C.,DeffenbaughD.,McNulty,D.,et.al.“Cross-LinkedGlenoidProsthesis:AWearComparisontoConventional Glenoid Prosthesis with Wear Particulate Analysis.” Journal of Shoulder and Elbow Surgery 2009.

17.DataonfileatDePuyOrthopaedics,Inc.WR#030290.

18.Orthocord® Suture is a registered trademark of DePuy Mitek Inc.